Clinical Trials Logo
  1. Home
  2. SARS-CoV-2 Infection
  3. NCT05263908
  4. Details
NCT05263908 Clinical Trial

A Study to Learn About PAXLOVID (a Commercial Medicine) In People With COVID-19

SARS-CoV-2 Infection Clinical Trial

Official title:
General Investigation for PAXLOVID PAC

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05263908
Other study ID # C4671018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 31, 2022
Est. completion date July 10, 2023

Study information
Verified date May 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this post marketing observational study is to learn about the safety and effects of the commercial medicine (called PAXLOVID) for the treatment of COVID-19. This study is intended to be registered with the participants who: - Have taken PAXLOVID PACK and have no history of using this medicine. - Are 12 years and older All participants will receive PAXLOVID, a standard treatment for COVID-19. Participants will take PAXLOVID 2 times a day by mouth or as prescribed. We will examine the experiences of people taking PAXLOVID. This will help us determine if PAXLOVID is safe and effective. Participants will be followed up for 28 days after taking PAXLOVID. During this time, participants will be closely watched for the safety and effects of PAXLOVID.

Description:

This is a multicenter cohort study to be conducted in individuals with SARS-CoV-2 infection who are treated with this product, and the investigator will enter the information required in this study in the case report forms (CRFs) based on the information obtained through medical records.

Recruitment information / eligibility
Status Completed
Enrollment 3346
Est. completion date July 10, 2023
Est. primary completion date July 10, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Subjects who are administered PAXLOVID PACK and have no history of using this drug. Exclusion Criteria: - There are no exclusion criteria for this study.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• nirmatrelvir / ritonavir
The usual dosage in adults and pediatric patients (=12 years of age weighing =40 kg) is 300 mg of Nirmatrelvir and 100 mg of ritonavir all taken together orally twice daily for 5 days.

Locations
Country Name City State
Japan Pfizer Local County Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse drug reactions 34 days
Secondary Ratio of subjects with worsening severity 34 days
See also
  Status Clinical Trial Phase
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04593641 - This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19) Phase 1
Recruiting NCT05200754 - Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19 Phase 2
Completed NCT04583995 - A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom Phase 3
Recruiting NCT06255860 - SARS-COV-2 Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study
Recruiting NCT04516811 - Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19 Phase 3
Recruiting NCT05012826 - Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID N/A
Completed NCT05007236 - Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection. Phase 2
Recruiting NCT06026514 - Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults Phase 1
Completed NCT05523739 - Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients Phase 1
Suspended NCT04738136 - Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia Phase 2
Recruiting NCT04584658 - Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
Recruiting NCT04547114 - Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
Completed NCT05119348 - Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments N/A
Completed NCT05096962 - COVID-19: SARS-CoV-2-CZ-PREVAL-II Study
Recruiting NCT04534400 - Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure
Completed NCT04527354 - Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia Phase 2
Completed NCT04583982 - ImmuneSense™ COVID-19 Study
Completed NCT05077176 - Phase 3 Booster Vaccination Against COVID-19 Phase 3
Completed NCT05584189 - COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability N/A

External Links